– Results from all subjects confirm excellent safety and tolerability and a large benefit across a variety of efficacy measures despite aggressive prednisone tapering-
– Positive data support Company’s plans to commence pivotal registration study in 2019 –
Englewood Cliffs, NJ (May 15, 2018) – Immune Pharmaceuticals, Inc. (NASDAQ: IMNP) (“Immune” or the “Company”), a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases, today announced that updated data from its phase 2 study of bertilimumab in patients with moderate-to-extensive bullous pemphigoid (BP) (study NCT02226146) are being presented today at the 2018 Pre-IID Pemphigus and Pemphigoid Symposium in Orlando, FL. These updated results include complete follow-up on all subjects enrolled in the study.
Subjects in the study experienced a decline in the Bullous Pemphigoid Disease Area Index (BPDAI) Activity Score of 81% (p=0.015) at day 84 from a mean baseline score of 67, with 86% of subjects showing at least a 50% improvement in the BPDAI Activity Score and 57% showing at least a 90% improvement. Over the course of the study, subjects in the study also had improvements in pruritus, a very challenging symptom for patients with BP, and quality of life. These benefits were seen quickly, with a mean reduction in BPDAI Activity Score of 70% by day 42. For a subgroup of subjects within which lesion healing was assessed, all six showed healing of prior lesions by day 28.
These improvements were observed despite subjects receiving only three doses of bertilimumab (on days 0, 14 and 28) and modest doses of prednisone that were aggressively tapered. The mean starting dose of prednisone was 28 mg (0.33 mg/kg) which was reduced to 17 mg (0.19 mg/kg) by day 42 (p=0.022) and to 12 mg (0.15 mg/kg) by day 84 (p=0.005). 40% of subjects had a prednisone dose of 10 mg/day or less by day 42, and 58% had achieved 10 mg/day or less by day 84. The standard of care for BP patients treated with systemic steroids is a starting dose of 0.5-1.0 mg/kg tapered slowly over the course of 6-12 months, and subjects in this study received on average approximately 2,900 mg less prednisone than called for by the regimen of Joly et al (Joly et al, New Engl J Med 2002; 347:143-145) and 1,700 mg less prednisone than called for by British treatment guidelines (Venning et al, Br J Dermatol 2012: 1200-1214).
These and additional results will be presented in an oral presentation by Neil Korman, MD, PhD, Director Clinical Trials Unit and the Murdough Family Center for Psoriasis, University Hospitals Cleveland Medical Center, and Professor of Dermatology, Case Western Reserve University School of Medicine, and a member of the Company’s Scientific Advisory Board, and in a poster to be presented by Immune’s Chief Medical and Operating Officer, Tony Fiorino, MD, PhD. Following the conference, the poster will be available on the Company’s website.
Dr. Fiorino stated, “I am gratified to have brought this important study to a close. The subjects in this study showed rapid improvement despite low doses of prednisone, which strongly suggests bertilimumab is active in bullous pemphigoid. Our next study will include a much longer treatment period, which could provide further benefits. We intend to discuss our plans for a randomized, controlled phase 2/3 study of bertilimumab in bullous pemphigoid with the FDA later this year, and we believe this next trial could serve as a registrational study in this orphan disease with no FDA-approved therapies. We expect to launch this pivotal study in 2019, using bertilimumab produced by our new manufacturing process.”
About the International Pemphigus & Pemphigoid Foundation (IPPF)
The International Pemphigus & Pemphigoid Foundation’s most important objectives are to provide patients and doctors worldwide with information about pemphigus and pemphigoid, and to provide patients and their caregivers much needed comfort and support so they can continue to live active, productive lives. To ensure that IPPF is able to provide the most current information about the disease and treatments, IPPF has developed and continue to maintain close relationships with doctors and leaders in the medical community, including the National Institutes of Arthritis, Musculoskeletal and Skin Diseases (NIAMS), part of the National Institutes of Health, and the American Academy of Dermatology (AAD). The IPPF is also an active member of a number of other organizations that help us fulfill our role as patient advocates and enable us to have more impact as we work together: National Organization of Rare Disorders (NORD), the Coalition of Skin Diseases (CSD), Derma Care Access Network (DCAN) and the International Alliance of Patient Organizations (IAPO). For more information, please visit the IPPF website.
About Immune Pharmaceuticals, Inc.
Immune Pharmaceuticals, Inc. is a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases. Immune’s lead program, bertilimumab, is a first-in-class, human monoclonal antibody that binds eotaxin-1, a chemokine that attracts eosinophils to the site of inflammation. By blocking eotaxin-1, bertilimumab may prevent the migration and activation of eosinophils and other cells, thus blocking an important inflammatory pathway active in a variety of allergic and immune diseases. Bertilimumab has shown promising clinical activity in bullous pemphigoid and has been studied in other conditions including allergic rhinitis and ulcerative colitis, and may have application in other diseases, including atopic dermatitis, asthma, and other diseases. Immune is also developing NanoCyclo, a nano-encapsulated formulation of cyclosporin, which is in late stage preclinical development for atopic dermatitis and psoriasis.
Safe Harbor Statements Regarding Forward Looking Statements
The statements in this news release made by representatives of Immune relating to matters that are not historical facts, including without limitation, those regarding future performance or financial results, the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Immune’s product candidates and the sufficiency of Immune’s cash and other capital resources, the continued development by Immune of bertilimumab or its determination to seek Orphan Drug designation for the pharmaceutical product of bertilimumab are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that actual performance or results could materially differ, that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, or Immune’s ability to fund such efforts with or without partners. Immune undertakes no obligation to update any of these statements. In addition, there can be no assurance that Immune will be able to reduce expenses, capitalize on strategic alternatives, develop its assets, and generate value for shareholders. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as to the date hereof. Accordingly, any forward-looking statements should be read in conjunction with the additional risks and uncertainties detailed in Immune’s filings with the Securities and Exchange Commission, including those discussed in Immune’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and periodic reports filed on Form 8-K.
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SOURCE Immune Pharmaceuticals Inc.